Recall Z-1759-2024 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
| Date | May 3, 2024 (initiated Mar 5, 2024) |
| Status | Open, Classified |
| Reason | Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods. |
| Root cause | Process design |
| Action | Consignees were emailed a Medical Device Correction notice dated 3/5/2024 instructing them to discuss the contents of the notification with their facility's Medical Director if affected units have been used, replace the IFU for affected devices with the one provided with the notification, and complete and return the provided response form by email to technical services@randox.com within five working days. Updated IFUs can be accessed at www.randox.com and questions can be directed to technical.services@randox.com. |
| Quantity | 80,366 units (US: 242 units; OUS: 80,094 units) |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053153 | RANDOX CALIBRATION SERUM Randox Laboratories, Ltd., Jan 13, 2006 |